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Completed Phase 2Phase 3 Interventional Results available

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

ClinicalTrials.gov ID: NCT00129545

Public ClinicalTrials.gov record NCT00129545. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Study identification

NCT ID
NCT00129545
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
800 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2005 (Type not available)
Primary completion
Aug 2013 (Actual)
Completion
May 2014 (Actual)
Last update posted
May 15, 2015

2005 – 2014

United States locations

U.S. sites
58
U.S. states
25
U.S. cities
49
Facility City State ZIP Site status
Advanced Cardiac Specialists Gilbert Arizona 85233 —
Arizona Arrhythmia Scottsdale Arizona 85251 —
Foundation for Cardiovascular Medicine La Jolla California 92037 —
Los Angeles Cardiology Associates Los Angeles California 90017 —
Cedars-Sinai Medical Center Los Angeles California 90048 —
El Camino Hospital Mountain View California 94040 —
Orange County Heart Orange County California 92868 —
UC Davis Medical Center Sacramento California 95817 —
St. John's Hospital / Pacific Heart Santa Monica California 90404 —
Washington Hospital Center Washington D.C. District of Columbia 20010 —
University of Miami Miami Florida 33136 —
Baptist Cardiac and Vascular Institute Miami Florida 33176 —
Bay Heart Group Tampa Florida 33607 —
Emory University Midtown Hospital Atlanta Georgia 30308 —
Piedmont Hospital Atlanta Georgia 30309 —
Emory University Hospital Atlanta Georgia 30322 —
University of Chicago Chicago Illinois 60637 —
North Shore University Evanston Illinois 60201 —
Loyola University Medical Center Maywood Illinois 60153 —
Prairie Education Research Cooperative Springfield Illinois 60637 —
Baptist Hospital West Lexington Kentucky 40503 —
University of Kentucky Lexington Kentucky 40536-0294 —
Terrebonne General Medical Center Houma Louisiana 70360 —
Ochsner Clinic New Orleans Louisiana 70121 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Michigan Medical Center Ann Arbor Michigan 48109 —
William Beaumont Royal Oak Michigan 48073 —
Abbott Northwestern Hospital Minneapolis Minnesota 55407 —
Mayo Clinic Rochester Minnesota 55902 —
St. Paul Heart Clinic Saint Paul Minnesota 55102 —
University of Mississippi Healthcare Center Jackson Mississippi 39216 —
St. Luke's Hospital Kansas City Missouri 64111 —
Nebraska Heart Institute Lincoln Nebraska 68526 —
Cooper University Hospital Camden New Jersey 08103 —
New Mexico Heart Institute Albuquerque New Mexico 87102 —
New York University Medical Center New York New York 10016 —
Columbia University Medical Center New York New York 10032 —
Mt. Sinai Medical Center New York New York — —
Summa Health System Akron Ohio 44304 —
Lindner Clinical Trial Center Cincinnati Ohio 45219 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Ohio State University Columbus Ohio 43210 —
Riverside Methodist Hospital Columbus Ohio 43214 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Harrisburg Hospital / Associated Cardiology Harrisburg Pennsylvania 17110 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
Presbyterian University Hospital Pittsburgh Pennsylvania 15213 —
Moffitt Heart & Vascular Wormleysburg Pennsylvania 17043 —
Mercy Medical Center West Knoxville Tennessee 37934 —
St. Thomas Research Institute Nashville Tennessee — —
Texas Cardiac Arrhythmia Austin Texas 78705 —
St. Lukes Episcopal Hospital Houston Texas 77030 —
Intermountain Medical Center Salt Lake City Utah 84107 —
University of Virginia Charlottesville Virginia 22908 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
Swedish Medical Center Seattle Washington 98104 —
Marshfield Clinic Marshfield Wisconsin 54449 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00129545, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 15, 2015 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00129545 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →